Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
This trial is active, not recruiting.
|Sponsor||Maruho North America Inc.|
|Start date||June 2013|
|End date||September 2015|
|Trial size||522 participants|
|Trial identifier||NCT01878461, M518101-US03|
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis
|United States||No locations recruiting|
|Other countries||No locations recruiting|
hide locations and contact info
|Mesa, AZ||Agave Clinical Research||no longer recruiting|
|Encino, CA||T Joseph Raoof||no longer recruiting|
|San Diego, CA||Medical Center for Clinical Research||no longer recruiting|
|San Diego, CA||Therapeutics Clinical Research||no longer recruiting|
|Santa Monica, CA||Clinical Science Institute||no longer recruiting|
|Denver, CO||Horizons Clinical Research Center||no longer recruiting|
|Aventura, FL||The Center for Clinical and Cosmetic Research||no longer recruiting|
|Jacksonville, FL||Jacksonville Center for Clinical Research||no longer recruiting|
|Skokie, IL||Northshore University Health System||no longer recruiting|
|South Bend, IN||South Bend Clinic||no longer recruiting|
|Overland Park, KS||Kansas City Dermatology||no longer recruiting|
|Louiville, KY||Derm Research||no longer recruiting|
|Lousville, KY||Dermatology Specialists Research||no longer recruiting|
|Baton Rouge, LA||Medical Development Center||no longer recruiting|
|Warren, MI||Grekin Skin Institute||no longer recruiting|
|St. Louis, MO||Washington University Dermatology||no longer recruiting|
|Henderson, NV||Karl G Heine Dermatology||no longer recruiting|
|Las Vegas, NV||Las Vegas Skin and Cancer Center||no longer recruiting|
|East Windsor, NJ||Center of Central New Jersey||no longer recruiting|
|Rochester, NY||Skin Search of Rochester||no longer recruiting|
|Stony Brook, NY||Derm Research Center of New York||no longer recruiting|
|Charlotte, NC||PMG Research of Charlotte||no longer recruiting|
|High Point, NC||Dermatology Consulting Services||no longer recruiting|
|Wilmington, NC||Medical Development Center||no longer recruiting|
|Cincinnati, OH||Radiant Research||no longer recruiting|
|Norman, OK||Central Sooner Research||no longer recruiting|
|Fountain Inn, SC||Palmetto Clinical Trial Servises||no longer recruiting|
|Mt Pleasant, SC||Coastal Clinical Research Center||no longer recruiting|
|Nashville, TN||Tennessee Clinical Research Center||no longer recruiting|
|Austin, TX||Austin Dermatology Associates||no longer recruiting|
|Austin, TX||DermResearch||no longer recruiting|
|Dallas, TX||Menter Dermatology Research Institute||no longer recruiting|
|San Antonio, TX||Clinical Trials of Texas||no longer recruiting|
|Salt Lake City, UT||Dermatology Research Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Proper quantity twice a day
Proper quantity twice a day
Investigator Global Assessment
time frame: 8 weeks after dosing
Male or female participants at least 18 years old.
- Who are able and willing to give signed informed consent
- Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
- Who have up to 20% of body surface area (BSA) afflicted with plaques
- Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
- Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study
- Whose serum calcium levels exceed the upper limit of reference range
- Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
- Who have been treated with systemic therapy within 30days of randomization.
- Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
- Who have been treated with topical therapy within 14days before the day of randomization.
|Official title||A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis|
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